Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2026-03-01 @ 12:23 AM
Study NCT ID:
NCT00982969
Status:
COMPLETED
Last Update Posted:
2010-07-20
First Post:
2009-09-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Clinical Utility of QuantiFERON in the Diagnosis of Active Tuberculosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014376', 'term': 'Tuberculosis'}, {'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-19', 'studyFirstSubmitDate': '2009-09-22', 'studyFirstSubmitQcDate': '2009-09-22', 'lastUpdatePostDateStruct': {'date': '2010-07-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tuberculosis', 'pneumonia', 'QuantiFERON-TB Gold in-tube', 'Tuberculin skin test'], 'conditions': ['Tuberculosis']}, 'referencesModule': {'references': [{'pmid': '21501477', 'type': 'DERIVED', 'citation': 'Lee JE, Kim HJ, Lee SW. The clinical utility of tuberculin skin test and interferon-gamma release assay in the diagnosis of active tuberculosis among young adults: a prospective observational study. BMC Infect Dis. 2011 Apr 18;11:96. doi: 10.1186/1471-2334-11-96.'}]}, 'descriptionModule': {'briefSummary': 'The investigators will evaluate the usefulness of QuantiFERON-TB Gold in-tube (QFT) in the diagnosis of active tuberculosis in young adults group, highly clinically suspected tuberculosis.', 'detailedDescription': 'Investigators will enroll prospectively all clinically and radiologically suspected tuberculosis patients from 20 to 29 years old who visited the Armed Forces Capital Hospital. Investigators will perform QFT and tuberculin skin test. Diagnosis of tuberculosis will be made by World Health Organization guideline and the physician will not know the QuantiFERON-TB Gold in-tube results before the diagnosis and anti-tuberculosis medication. Investigators will evaluate the sensitivity and specificity of QuantiFERON-TB Gold in-tube in the diagnosis of active tuberculosis among young adults.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Soldiers in South Korean Army', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All clinically and radiologically suspected TB patients from 20 to 29 years old who visited the Armed Forces Capital Hospital\n\nExclusion Criteria:\n\n* Soldiers who do not agree with study protocol'}, 'identificationModule': {'nctId': 'NCT00982969', 'briefTitle': 'The Clinical Utility of QuantiFERON in the Diagnosis of Active Tuberculosis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Armed Forces Capital Hospital, Republic of Korea'}, 'officialTitle': 'The Clinical Utility of QuantiFERON in the Diagnosis of Active Tuberculosis Among Young Adults', 'orgStudyIdInfo': {'id': 'QFTinROKmilitary'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TB suspected', 'description': 'Soldiers who are clinically suspected with tuberculosis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-040', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Armed Forces Capital Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Armed Forces Capital Hospital, Republic of Korea', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Sei Won Lee/Division chief of pulmonology', 'oldOrganization': 'Armed Forces Capital Hospital'}}}}